To the consortium of SF95 filers:
Any changes you would like to make? It will be sent to CDER Ombudsman & Woodcock today ASAP
Virginia,
A consortium of Amarin stakeholders request that Dr. Janet Woodcock reinstate Anchor SPA immediately. (Before Wednesday June 17th) These stakeholder have exhausted ALL administrative means by submitting and commenting to Citizen Petition FDA-2013-P-1612. On March 27th Dr. Woodcock sent denial letters to these stakeholders that effectively covers ALL Amarin stakeholders; Dr. Woodcock uses a non-finalized guidance document to excuse the denial. This excuse is not convincing nor will it hold up in court.
In her official duties Dr. Janet Woodcock was directly Negligent supervising numerous CDER employees. Specifically the last Official meeting held to discuss Amarin’s SPA appeal. At this level Dr. Woodcock was the ranking member of this meeting and with her vast regulatory experience she did not stop and inform the committee they MUST reinstate Anchor SPA CDER. The excuse of rescindment was outside FDA Regulatory jurisdiction and scheme. The FDA does not have the jurisdictional powers to practice medicine, in fact the courts have ruled on this numerous times. The judgement used by FDA to rescind SPA was not a safety or efficacy judgement, it was a medical judgement. Furthermore, this medical judgement does not meet the current standard of care.
These actions and damages are cognizant under Federal Tort Claims Act (FTCA) and are ripe to be submitted.
Numerous stakeholders intend to file and follow through to Class Action if needed.
Amarin stakeholders respectfully request , in the full scope of her administrative powers, Dr. Woodcock reinstate Anchor SPA.
Please send a receipt this message was received by your office.
Thank You,
